Kornimate/medical-research-clean huggingface dataset:
metabolism and sleep apnea treatment

Conditions: Obstructive Sleep Apnea; Fat Disorder

Summary: the purpose of this research study is to see if obstructive sleep apnea (osa) is associated with abnormalities in fat metabolism. through this research study, the investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.


Eligibility criteria:
aim 1 group: inclusion criteria: * age between 18-70 years * ability to provide consent exclusion criteria * body mass index (bmi) \> 40 kg/m2 * prevalent myocardial infarction, coronary revascularization, heart failure, and stroke * type 1 or type 2 diabetes mellitus * current or prior use of pap or oral appliance therapy for osa * use of oral corticosteroids * unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression) * other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h) * use of supplemental oxygen during wakefulness or sleep * central sleep apnea, obesity hypoventilation syndrome or cheyne-stokes respiration based on the home sleep test * resting awake oxygen saturation (spo2) \< 90% aim 2 group: inclusion criteria: * age between 18-70 years * ability to provide consent * moderate-to-severe osa (ahi ≥ 15/h); * demonstration of positive airway pressure (pap) use of \> 4 h/night on 70% of the nights during 1-week run-in period * successful completion of all of the procedures for aim 1. exclusion criteria: * bmi: ≥ 40 kg/m2 * type 1 or type 2 diabetes mellitus * current use of pap or oral appliance therapy for osa * commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years * epworth sleepiness score of 18 or more * use of oral corticosteroids * participation in another clinical trial * unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression) * other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h) * use of supplemental oxygen during wakefulness or sleep * central sleep apnea, obesity hypoventilation syndrome or cheyne-stokes respiration based on the home sleep test * resting awake spo2 \< 90%
effects of position and a test meal on esophago-gastric junction morphology and function assessed by high-resolution impedance manometry (hrm)

Conditions: Hiatus Hernia

Summary: retrospective analysis for hrm measurements using liquid swallows and a test meal for the presence of hiatal hernia. the investigators will correlate hernia descriptions with presence of acidic reflux and clinical complaints.

we will retrospectively analyze all patients referred to hour unit for high-resolution esophageal manometry. these patients have been tested using liquid swallows and a test meal. we will analyze the hrm measurements for presence of manometric signs of hiatal hernia and determine predictive factors for hernia presence. we will correlate hernia description versus presence of acid reflux, clinical complaints and hrm measurements.

Eligibility criteria:
inclusion criteria: * all patients referred to our functional lab for esophageal high-resolution manometry from january 2013 - december 20165 * lack of documentation of patient preferences against usage of medical data for biomedical research * male and female patients ≥18 years of age exclusion criteria: * age under 18 years * patient's wishes against scientific use of their clinical data
an open-label study of celecoxib in patients with posttraumatic pain

Conditions: Pain

Summary: to investigate efficacy, safety and tolerability of celecoxib in patients with posttraumatic pain for the duration of 8 days.


Eligibility criteria:
inclusion criteria: * patients with posttraumatic pain which is able to be controlled with an oral nsaid * patients with "pain" that meets both of the following criteria within 48 hours after injury: "pain" pain intensity (categorical): "moderate pain" or "severe pain" pain intensity (vas): 45.0 mm or more * patients with "inflammation" that meets the following criteria within 48 hours after injury. "inflammation" categorical: "mild", "moderate" or "severe" exclusion criteria: * patients who have received analgesics and anaesthetics for injury * patients with a history/complication of aspirin-induced asthma * patients taking excluded medications * patients with a history/complication of ischaemic heart disease, serious cardiac arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a history/plan of revascularization

Keywords: posttraumatic pain
a study to characterize epidemiology, clinical and genetic features of kallmann syndrome in finland

Conditions: Kallmann Syndrome

Summary: objective is to characterize epidemiology, clinical and genetic features of kallmann syndrome in finland.

kallmann syndrome is comprised of idiopathic hypogonadotropic hypogonadism and anosmia (inability to smell). associated phenotypes may include cryptorchidism, microphallus, bone deformations, mirror movements, hearing loss and infertility. objective is to characterize epidemiology, clinical and genetic features of kallmann syndrome in finland.

Eligibility criteria:
inclusion criteria: * kallmann syndrome * age 15 yrs or more exclusion criteria: * severe mental retardation

Keywords: kallmann syndrome hypogonadotropic hypogonadism
fungal resistance in dermatophyte infection

Conditions: Dermatophyte Infection

Summary: the aim of the study is to compare the efficiency of broth microdilution versus disk diffusion method for antifungal drug susceptibility testing of the most used drugs in dermatophytosis treatment.


Eligibility criteria:
inclusion criteria: * patients diagnosed clinically with dermatophytosis, any age group and any sex exclusion criteria: * patients under either local or systemic antifungal treatment
return to play checklist

Conditions: Labral Tear, Glenoid

Summary: this study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair.


Eligibility criteria:
inclusion criteria: - males and non-pregnant females aged 15 years or older with a capsulolabral tear undergoing arthroscopic capsulolabral repair surgery at the rothman institute with one of the investigators exclusion criteria: * patients with an labral repair * patients only undergoing debridements with no repair * patients undergoing revision shoulder surgery or those with a history of multiple shoulder surgeries * concomitant severe glenohumeral arthritis or adhesive capsulitis * patients with a worker's compensation claim * patients diagnosed with psychological disorders * patients with a history of alcohol or drug abuse -patients on preoperative narcotic therapy -
evaluation of efficacy and safety of specific immunotherapy with modified allergen extracts of house dust mites

Conditions: Allergic Rhinitis

Summary: the objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.


Eligibility criteria:
inclusion criteria: * positive history of perennial allergic rhinitis due to house dust mites * positive screening skin prick test (wheal diameter \> 3 mm) * compliance and ability of the patient to complete a diary card for self-evaluating of the symptoms and antisymptomatic medication * signed and dated patient´s informed consent, exclusion criteria: * previous immunotherapy with mite extracts within the last 3 years, * simultaneous participation in other clinical trials, * other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), * auto-immune disorders, * severe chronic inflammatory diseases, * malignancy, * alcohol abuse, * existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, * treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
primary stability of immediate implant using versah versus conventional burs

Conditions: Edentulous Alveolar Ridge

Summary: this study is designed as a prospective randomized clinical trail, evaluate the effect of osseodensification technique on primary stability in comparison to the conventional drilling technique in immediate single fresh extraction sockets.

in this study, 30 dental implants inserted immediately after tooth extraction (not a multi-rooted tooth) as a two groups according to bur drill technique and measure the primary stability by osstell devise based on resonance frequency analysis (rfa) value which is scaled from 1-100, after 16 weeks measuring the secondary stability.

Eligibility criteria:
inclusion criteria: * healthy and medically fit patients * patients age ≥18 years for both gender * apical bone ≥ 2mm from vertical structure showed in x-rays. * patient has tooth or teeth with single root anterior and\\or posterior area cannot * restored by another dental treatment procedure. exclusion criteria: * patient with active periodontal disease. * pregnancy or lactation. * a local or systemic disorder that is contraindicated for the minor surgical procedure * and may affect healing process. * any irradiation in head and neck area. * heavy smoking habit.
maternal vitamin d for acute respiratory infections in infancy

Conditions: Upper Respiratory Tract Infections; Lower Respiratory Tract Infections

Summary: there is a growing body of data suggesting that vitamin d modulates the host's immune response to acute respiratory infection (ari). the primary aim of this study is to determine whether maternal vitamin d3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ari among infants in dhaka, bangladesh. secondary outcomes include: a) incidence of ari associated with specific major pathogens, b) incidence of clinical ari (without the need for positive microbiology), and c) quantitative density of pneumococcal carriage. infants will be followed from birth until 6 months of life. among infants who meet at least one of the specific case definitions for ari (see 'detailed description' section), nasal swab specimens will be collected. respiratory samples will be analyzed by real-time polymerase chain reaction (qpcr) to identify a 7-virus panel (influenza a and b, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of s. pneumonia.

in this study, an acute respiratory infection (urti and/or lrti) has been clinically defined as: a) upper respiratory tract infection (urti) a new-onset illness consisting of at least two of the following clinical criteria at any time during a surveillance week: * caregiver-reported cough; * caregiver-reported rhinorrhea; * caregiver-reported nasal congestion; and, * measured axillary temperature greater than or equal to 37.5°c. b) lower respiratory tract infection (lrti) 1. new onset clinically-diagnosed lrti: * caregiver-reported cough and/or difficulty breathing during a surveillance week; and, * observed lower chest wall indrawing and/or elevated respiratory rate (60 breaths per minute or greater for infant up to 59 days of age, or 50 breaths per minute or greater for infant 60 days of age or older) 2. hospitalized lrti * hospitalization with physician diagnosis of pneumonia or bronchiolitis

Eligibility criteria:
inclusion criteria: * infants born to women enrolled in the mdig trial (nct01924013). * maternal inclusion criteria (at time of enrolment) will be: * at least 18 years of age * 17 to 24 completed weeks of gestation * intends to permanently reside in the trial catchment area for at least 18 months * family plans to reside in catchment area for the first 6 months postnatal * provides written informed consent for participation exclusion criteria: * mother withdrawn from mdig trial prior to delivery * failure to provide consent for participation in sub-study

Keywords: bangladesh vitamin d acute respiratory infections infancy pregnancy
clinical effect and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder

Conditions: Safety Issues;Effect of Drugs

Summary: to study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.

this is a phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. the timing of treatment is any time after the diagnosis of autism spectrum disorder. the investigator will proceed the groups during the same period. 1. demographic data and baseline characteristics of the studied group were collected: * basic patient's information survey * medical history * physical examination * basic blood test result * autism behavior checklist,cars before the treatment * brain magnetic resonance imaging-diffusion tensor imaging (mridti) before the treatment * neurocognitive function test before the treatment 2. assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded. 3. autologous cord blood doses is 20-30ml (total mononuclear cells# 1\*10\^7/kg)#the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo. 4. the follow-up: clinical test until 24th month in 3 month gaps.

Eligibility criteria:
inclusion criteria: * • a patient who was diagnosed with asd. exclusion criteria: * • in case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial. * accompanied by a serious disease, such as chromosome abnormality, etc. * in case where a patient's medical condition is judged to be maladapted by a researcher. * in case a patient or his or her legal representative doesn't agree to participation in a clinical trial. * a patient having a predisposition to allergies. * a patient having serious disorders in the liver, kidney, and cardiopulmonary function.

Keywords: autism spectrum disorder;autologous umbilical cord blood;safety;effect
study of metabolic modifications in children with noonan syndrome

Conditions: Child Syndrome

Summary: noonan syndrome (ns) is a rare genetic disease (incidence 1/2500 live births) characterized by the association of craniofacial manifestations, cardiopathies, short stature, and tumor predisposition. the genetic causes of noonan syndrome are mutations of genes involved in the ras/mitogen-activated protein kinases (mapk) pathway, mainly the gene encoding the tyrosine phosphatase shp2 (50% of patients).shp2 appears to be involved in many facets of energy metabolism control (glucose homeostasis, adipose tissue function...), through mechanisms that are poorly understood. several metabolic anomalies (reduced adiposity, improved glucose tolerance) have been recently identified in an original mouse model carrying shp2 mutation. moreover, recent clinical survey has shown that adult noonan syndrome patients are protected from developping overweight and obesity when compared to the general population. however, the metabolic status associated with noonan syndrome condition has not been explored to date.

differential hormone sensitivity is associated with noonan syndrome and participates in the development of some symptoms. the investigators have demonstrated that mapk upregulation in noonan syndrome is responsible for partial growth hormone (gh) insensitivity, and subsequent growth retardation. clinical traits evocative of energy metabolism dysfunctions have been recently reported in noonan syndrome patients, although the origins and consequences of these metabolic changes have not been documented to date. the aim of this study is to explore the metabolic status of children with noonan syndrome. children with noonan syndrome will be compared with age- and sex-matched healthy children. the investigators hypothesize than noonan syndrome children have an increased insulin sensitivity compared to ghd children. study parameters will be collected including: clinical measurements (height, weight, body mass index, waist circumference, and blood pressure), glucose and insulin levels at baseline and after an oral glucose tolerance test (ogtt), body composition measured by dual-energy x-ray absorptiometry (dxa). the study will include only one visit.

Eligibility criteria:
inclusion criteria: * noonan syndrome genetically confirmed * informed consent obtained from children and parents exclusion criteria: * chronic disease associated with variation of insulin sensitivity: body mass * treatment associated with variation of insulin sensitivity: corticoid treatment \> 5 days preceding the study inclusion * tumoral disease (leukemia) in treatment

Keywords: insulin sensitivity metabolism noonan syndrome shp2
a bioequivalence study comparing two different strengths formulations of insulin lispro in patients with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: primary objective: to demonstrate bioequivalence between insulin lispro given as sar342434, 200 units/ml test formulation (t) and insulin lispro 100 units/ml reference formulation (r) after a single subcutaneous (sc) dose secondary objectives: * to assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (t) in comparison to the reference formulation (r) after a single sc dose * to assess the safety and tolerability of the test and the reference formulation of insulin lispro

study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose

Eligibility criteria:
inclusion criteria : * male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year * total insulin dose of \<1.0 u/kg/day * fasting serum c-peptide \<0.30 nmol/l at screening * glycohemoglobin (hba1c) ≤75 mmol/mol (≤9%) at screening * stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study). * patients with anti-insulin antibody titer at screening ≤ 30.0 ku/l * body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18 and 30.0 kg/m², inclusive exclusion criteria: * any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of hit-type ii (heparin induced thrombocytopenia type ii) * more than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. * frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month). * symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmhg within 3 minutes when changing from supine to standing position. * presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * if female, pregnancy (defined as positive β-hcg blood test), breast-feeding the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study to evaluate the effect of benralizumab on allergen-induced inflammation in mild, atopic asthmatics

Conditions: Asthma

Summary: this is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.

this randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks for 3 doses on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen. approximately 38 non-smoking men and women (18 - 65 years of age) corticosteroid-free (oral and inhaled) mild, atopic asthmatics who have demonstrated a dual (early and late) asthmatic response to inhaled allergen challenge at screening will be recruited to complete the study.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. female or male aged 18 to 65 years, inclusively, at the time of enrolment. 3. general good health 4. mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta 2 agonists (not more than twice weekly) 5. positive skin-prick test to at least one common aeroallergen exclusion criteria: 1. current lung disease other than mild allergic asthma 2. any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic 3. any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period 4. history of anaphylaxis to any biologic therapy or vaccine

Keywords: asthma
the effect of repeated prefrontal cortex stimulation on antisocial and aggressive behavior

Conditions: Antisocial Behavior; Aggression

Summary: this study investigates the relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior. in the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete survey and laboratory measures assessing antisocial behavior and risk factors. heart rate and skin conductance will also be measured.


Eligibility criteria:
inclusion criteria: * above 18 years of age * able to understand the nature of the study and give informed consent exclusion criteria: * currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications * currently consuming anti-depressants * history of seizures * metallic implants on the scalp * participation in other transcranial magnetic stimulation (tms) or tdcs experiments on the same day * history of adverse reactions to tdcs

Keywords: antisocial behavior aggression transcranial direct current stimulation dorsolateral prefrontal cortex associated risk factors